2019 Chongqing drug review and inventory: 11 pharmaceutical companies applied for 36 acceptance numbers of conformity assessment, and 8 varieties were approved

Influenced by clinical verification, consistency evaluation and new policies on drug registration, the number of drug acceptances in 2016 and 2017 dropped significantly, and the total number of drug acceptances decreased significantly In 2018, the total acceptance volume of the whole country basically returned to normal, and in 2019, it was on the rise What was the situation of drug declaration in Chongqing in 2019? 1、 According to the latest statistics of drug intelligence registration and acceptance database, in 2019, CDE undertook 108 new drug registration applications in Chongqing with acceptance number (excluding reexamination, the same below), an increase of 71.4% compared with 2018, accounting for only 1.36% of the total accepted drugs in China In terms of the number of registration applications, although Chongqing pharmaceutical enterprises have not fully stepped out of the impact, they have shown a warming trend Figure 1 drug acceptance in Chongqing from 2011 to 2019 note: data as of December 26, 2019 In 2019, the number of drug applications accepted by CDE in Chongqing (based on the acceptance number) ranked eighteenth among all provinces and municipalities in China, accounting for 18.3% of the annual number of drug applications accepted by Jiangsu province (see Figure 2) Figure 2 drug acceptance of CDE in all provinces and cities in 2019 note: data as of December 26, 2019 In terms of the declaration of various drug types, the acceptance of chemical drugs is the main one, followed by biological products The declaration of biological products mainly starts from 2013, with 14 acceptance numbers in 2019 Figure 3 acceptance of drug types in Chongqing from 2011 to 2019 note: data as of December 26, 2019 The following specific analysis of the registration, acceptance and evaluation of chemical drugs, traditional Chinese medicine and biological products: 1 In 2019, a total of 86 chemical drugs were accepted, including 3 new drugs, 19 generic drugs and 64 supplementary applications (see Figure 4) Figure 4 acceptance of CDE Chongqing chemical drugs in 2011-2019 note: data as of December 26, 2019 1.1 consistency assessment is affected by the general trend of consistency approval documents From the perspective of acceptance, it is mainly generic drugs and supplementary applications, including 36 consistency assessments included in supplementary applications, accounting for 3.52% of the total acceptance of national consistency assessment in that year (if you want to know the specific situation, please pay attention to the acceptance database of pharmaceutical intelligence registration) Figure 5 acceptance quantity of consistency evaluation of enterprises in Chongqing in 2019 note: data as of December 26, 2019 In this year's chemical consistency evaluation application ranking, Fuan Pharmaceutical Group qingyutang Pharmaceutical Co., Ltd led the list, with 9 application acceptance numbers, Southwest Pharmaceutical Co., Ltd ranked second, Chongqing Huabang Pharmaceutical Co., Ltd ranked third See the following table for the specific acceptance: Table 1 acceptance of consistency assessment in Chongqing in 2019 note: the data is up to December 26, 2019 2 there are 11 applications for registration of Chongqing Traditional Chinese medicine undertaken by CDE in 2019, all of which are supplementary applications Figure 6 number of accepted traditional Chinese medicine in Chongqing from 2011 to 2019 note: data as of December 26, 2019 Table 2 acceptance of traditional Chinese medicine in Chongqing in 2019 note: data as of December 26, 2019 3 in 2019, 14 acceptance numbers of biological products in Chongqing were accepted by CDE, including 2 new drugs and 12 supplementary applications Figure 7 Acceptance quantity of biological products in Chongqing from 2013 to 2019 note: data as of December 26, 2019 Table 3 acceptance of biological products in Chongqing in 2019 note: data as of December 26, 2019 2、 Review and approval of drug registration in Chongqing in 2019 According to the latest statistics of pharmacy intelligence registration and acceptance database, in 2019 (the start date of the status is from January 1, 2019 to December 26, 2019), there are 23 acceptance numbers (referring to the number of varieties that CDE has completed the technical review and transferred for approval, and the processing status includes the status of approval, approval or certification completion, calculated by the acceptance number) In addition, there are 8 other clinical trials with implied license acceptance number, which are approved by default Figure 8 number of drug registrations in Chongqing in 2019 note: data up to December 26, 2019 Table 4 approved clinical / approved production in Chongqing in 2019 note: data as of December 26, 2019 Data source: drug intelligence registration and acceptance database listening statement: this point of view only represents the author, not the position of drug intelligence network, welcome 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